Opti Lion Electrolyte Analyzer, Model GD7200

• • Terminated Z-0029-2014 FDA Class II ·initiated 9 Aug 2013 ·on shared 510(k) K052027

  OPTI LION E-Plus Cassettes were labeled with an incorrect barcode. The incorrect barcode could perfect the performance of one or more parameters as the product ages. Also a Customer complaint from a distributor reported that a customer was getting QC failures.

• • Terminated Z-2558-2011 FDA Unclassified (pre-2012) ·initiated 15 Mar 2011

  The values reported by the chloride sensors may report erroneous values below specification on aqueous controls and potentially with patient samples of whole blood and serum/plasma.

• • Terminated Z-1083-2010 FDA Unclassified (pre-2012) ·initiated 20 Apr 2009

  Outer box labeling shows an incorrect storage temperature range.

• • Terminated Z-0119-2008 FDA Unclassified (pre-2012) ·initiated 18 Jul 2007 ·on shared 510(k) K052027

  Incorrect results/stability failure; Actual device stability studies show sodium and chloride sensors age differently than anticipated when stored at the high end of labeled storage, therefore subsequent measurements give results outside the allowed error allowance before the 6 month expiration date shown on the device.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K052027 ↗

FDA Product Code

CGZ

Device Class

Class II

Regulation

21 CFR Part 862.1170

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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